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Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae

NCT07396571 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 535

Last updated 2026-03-02

No results posted yet for this study

Summary

The goals of this observational study are to identify risk factors for ESBL-producing Enterobacterales and carbapenemase-producing Enterobacterales (CPE) colonization in oncohematological patients with severe neutropenia, and to develop and validate a predictive model of infection caused by ESBL-producing Enterobacterales and CPE in patients previously colonized by the same bacteria.

The main questions the study aims to answer are:

* What are the risk factors for ESBL-producing Enterobacterales and CPE colonization in patients with severe neutropenia?
* Can a predictive model be developed to accurately predict infections in the colonized patients?

Study Design \& Participants: Participants will be screened after receiving neutropenia-inducing treatment (e.g., chemotherapy, chimeric antigen receptor T-cell (CAR-T) therapy, or others). A baseline rectal swab will be collected to assess initial colonization status, followed by weekly swabs throughout the duration of neutropenia. Patients will be followed for 90 days from initial screening, during which the study team will record any infections, with an additional 30-day follow-up period. All hospitalization data will be recorded.

Conditions

  • Hemato-oncologic Patients
  • Colonization
  • Neutropenia
  • Enterobacteria Non Susceptible to Carbapenem Carrier
  • ESBL-producing Enterobacteriaceae Infections

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Zaira R. Palacios Baena, MD/PhD · Virgen Macarena hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-05-31
Completion
2028-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07396571 on ClinicalTrials.gov